Sodhi Medical Services

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #1, the laboratory failed to follow policies and procedures regarding annual preventative maintenance service for the Zeiss Axiostar plus (Serial Number: 176045) microscope used for microscopic examination of urine sediment in the subspecialty of urinalysis in 2023 and 2024. Findings include: 1. Review of laboratory policies and procedures revealed the policy, "Laboratory Policies", which stated, under "Care of the Microscope", "Zeiss microscope will be contacted annually for preventative maintenance service." 2. Review of laboratory records revealed no documentation of annual preventative maintenance on the Zeiss Axiostar plus (Serial Number: 176045) microscope in 2023 and 2024. 3. Interview with TP #1 on 02/27/2024, at 12:43 pm, confirmed the laboratory failed to follow policies and procedures 3regarding annual preventative maintenance service for the Zeiss Axiostar plus (Serial Number: 176045) microscope used for microscopic examination of urine sediment. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with testing personnel (TP) #1, the laboratory failed to include all the required components of a laboratory test report including the facility's address for 14 of 14 patient test reports reviewed in the subspecialty of routine chemistry. Findings include: 1. Review of laboratory policies and procedures revealed the policy, "Laboratory Policies", which stated, under "Reporting and Forms", "[The] Laboratory test report forms will state the facility name and address." 2. Review of laboratory records, including patient test reports, revealed 14 of 14 patient test reports reviewed lacked the facility's address where testing in the subspecialty of routine chemistry was performed. Date: Patient MRN*: 02/23/2023 4259.0 02/23/2023 4437 02/23/2023 3774 02/23/2023 4729 07/19/2023 4509 07/19/2023 11630 11/09/2023 9182 11/09/2023 7124.0 03/28/2024 9510 03/29/2024 12768 08/07/2024 10831 08/07 /2024 7647 12/17/2024 6697 12/17/2024 5626.0 [*MRN = Medical Record Number] 3. Interview with TP #1 on 02/27/2025, at 1:19 pm, confirmed the laboratory failed to include all the required components of a laboratory test report including the facility's address in the subspecialty of routine chemistry. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #1; the laboratory director (LD) failed to attest to the routine integration of proficiency testing samples into the patient workload using the laboratory's routine methods for microscopic urinalysis testing. Findings include: 1. Review of the 2021 Hematology /Coagulation Proficiency testing (PT) event two failed to identify the testing personnel which performed urine sediment testing. 2. Review of the 2020 Hematology /Coagulation Proficiency testing (PT) event three failed to identify the testing personnel which performed urine sediment testing. 3. Review of the 2020 Hematology /Coagulation PT event two revealed that the LD failed to sign the attestation statement under the header "Lab Director or designee" to attest to the routine integration of samples into the patient workload using the laboratory's routine methods. 4. During survey date of 10-6-2021 at 10:37 A.M., TP #1 confirmed that the LD ran the urine sediment test, but the LD did not sign the attestation statement under the header "Person(s) Performing the Test.". 5. Interview with TP#1 on 10-6-2021 at 2:57 pm confirmed the above findings. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of laboratory records, direct observation, and interview with testing personnel (TP) #1; the laboratory failed to attain a score of at least 80 percent of acceptable responses for the analyte glucose from the second proficiency testing (PT) event of 2019, resulting in unsatisfactory analyte performance for the testing event. Findings include: 1. Review of the 2019 routine chemistry PT event two identified a score of 20% for analyte, glucose. 2. Review of PT documentation found no

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)